This is a multicenter, double-blind, randomized, placebo-controlled phase Ⅱ study to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of YN-011 in subjects with overweight (27 kg/m2 ≤ BMI \< 30 kg/m2, with at least one comorbidity) or obesity (BMI ≥ 30 kg/m2, with or without comorbidities). The entire study period will consist of a 2-week screening period, a 22-week double-blind treatment period, and a 4-week off-treatment follow-up period
Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent form (ICF);
Male or female subjects, aged 18 to 75 years (both inclusive) at the time of signing the ICF;
Obese: BMI ≥ 30.0 kg/m2, with or without comorbidities; Or overweight: 27.0 kg/m2 ≤ BMI < 30.0 kg/m2, with at least one of the following weight-related comorbidities: pre-diabetes, hypertension, dyslipidemia, fatty liver, osteoarthritis, or obesity-induced obstructive sleep apnea syndrome (If the subject has only fatty liver as a comorbidity, imaging results within the 3 months prior to screening are required for fatty liver);
A self-reported change in body weight less than 5.0% controlled with diet and exercise within 3 months before screening;
Obesity caused by endocrine disease or monogenic mutation, including but not limited to hypothalamic obesity, pituitary obesity, hypothyroidism-related obesity, Cushing's syndrome, insulinoma, acromegaly or hypogonadism;
Known or suspected allergy to the investigational medicinal product, its components or drugs of the same class;
Previously diagnosed diabetes mellitus (including type 1 diabetes mellitus, type 2 diabetes mellitus, diabetes mellitus due to pancreatic damage, or other types of diabetes mellitus [except gestational diabetes mellitus]);
History of severe gastrointestinal disease (e.g., active ulcers), or gastrointestinal surgery (except for appendectomy, cholecystectomy, or other gastrointestinal endoscopic surgeries deemed by the investigator to have no significant impact on gastrointestinal motility), or clinically significant gastric emptying abnormalities (e.g., pyloric obstruction, gastroparesis), or long-term use of drugs with direct effects on gastrointestinal motility within 6 months before screening, or those who were not suitable for participating in this study at the investigator's discretion;
Parallel
Efsubaglutide Alfa 20 mg QW
DrugEfsubaglutide Alfa 20 mg QW
Efsubaglutide Alfa 40 mg QW
DrugEfsubaglutide Alfa 40 mg QW
Efsubaglutide Alfa 40 mg Q2W
DrugEfsubaglutide Alfa 40 mg Q2W
Efsubaglutide Alfa 80 mg QW
DrugEfsubaglutide Alfa 80 mg QW
Efsubaglutide Alfa 80 mg Q4W
DrugEfsubaglutide Alfa 80 mg Q4W
Placebo
Other interventionPlacebo
Percentage change (%) of body weight from baseline after subcutaneous administration of YN-011 for 22 weeks
Proportion of subjects with body weight loss ≥ 5%, ≥ 10%, and ≥ 15% from baseline after subcutaneous
Absolute change from baseline in body weight (Kg) after subcutaneous administration for 22 weeks
Changes from baseline in BMI after subcutaneous administration for 22 weeks
Changes from baseline in waist to hip circumference ratio after subcutaneous administration for 22 weeks
waist circumference, hip circumference,
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